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Podcasts

Webcast: Risk Management for Pharmaceutical Manufacturing and Equipment: Meeting Regulatory Expectations and Preventing Contamination
On-Demand—Sponsored by Alfa Laval

Webcast: A Unique Workflow for Linearity Using Automated Sample Preparation and UHPLC
On-Demand—Sponsored by Dionex & Mettler-Toledo

Webcast: Solubilization and Stability of Drug Actives
On-Demand—Sponsored by Croda

Webcast: Protect IP and Reduce the "Sign and Witness" Burden in Lab Informatics Systems
On-Demand—Sponsored by Surety

Podcast: Interviews with AAPS 2010 Science Award Winners

Podcast: Thomas Otto on Vetter Secondary Packaging

Podcast: Lou Schmukler on Pfizer's Manufacturing Strategy

Podcast: Joseph Forth of AMRI on Clinical Formulations

Events

InformexUSA 2011
Feb. 7–11
Charlotte, NC

Pharma Test Expo 2011
Feb. 8–10
Cologne, Germany

QA/QC Strategy for Biologics and Biopharmaceuticals
Feb. 9–11
King of Prussia, PA

Lyophilization Technology — Practical Application of the Scientific Principles
Feb. 14–15
King of Prussia, PA

PHARMA WORLD EXPO 2011
Feb. 23–26
Mumbai

Pharmapack
Feb. 23–24
Paris

Biosimilars and Follow-On Biologics Americas
Feb. 28–Mar. 2
Boston

Biomanufacturing and Single Use Systems Asia
Mar. 7–9
Shanghai

Sterilization Procedures: Technology, Equipment & Validation
Mar. 9–10

Pittcon 2011
Mar. 13–18
Atlanta

DCAT Week 2011
Mar. 14–17
New York

More events


FindPharma Search
February 3, 2011 PharmTech.com

News

President Obama's State of the Union Address Favorably Received by Pharma Industry
The President’s speech, delivered last week to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.
Click Here to Read More

EMA Releases Revised Computerized Systems Annex to GMP Guide
The European Medicines Agency released Annex 11–Computerized Systems, a supplement to its GMP Guide Chapter 4 on Documentation. Click Here to Read More

Senators Reintroduce Bill to Curb Pay-for-Delay Settlements
Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act,” which would presume that pay-for-delay settlements were illegal. Click Here to Read More


Product Spotlight

Incubators offer thermal protection

Caron’s GelJacket benchtop carbon-dioxide incubators incorporate an active insulation gel designed to offer a high level of thermal protection. The GelJacket insulation has a volumetric heat capacity 40 times greater than that of water, according to the company. This characteristic helps the insulation maintain the incubator’s temperature effectively when its door is opened or power is lost. The gel is sealed within the incubator, thus reducing the risk of leakage.

Unlike water-jacket incubators, which require manual cleaning, the GelJacket incubators withstand high temperatures and offer an automatic, 90 °C, moist-heat decontamination cycle. The incubators’ decontamination cycle is designed for easy use, and it cleans the units overnight.

Refrigerated and nonrefrigerated versions of the GelJacket incubator are available. The refrigerated unit has a standard temperature range of 5–60 °C for applications in which the heat generated by culturing techniques must be removed. The incubators include an infrared sensor that helps to maintain carbon-dioxide levels.

 
Company Notes
Alexion Pharmaceuticals, a biopharmaceutical company, acquired Taligen Therapeutics, a development-stage biotechnology company, for $111 million in cash. Additionaly, Alexion will pay Taligen development and regulatory milestone payments for up to six products in the United States and European Union.

Arena Pharmaceuticals will reduce its US workforce by approximately 25%, or 66 employees, by March 28, 2011. The company said in a statement that it will focus its resources on working to obtain regulatory approval of its obesity drug lorcaserin, seeking collaborators for the commercialization of lorcaserin outside of the US, and advancing select earlier-stage research and development programs independently or in partnership.

Bristol-Myers Squibb and sanofi aventis received from FDA an additional six-month period of exclusivity to market Plavix (clopidogrel bisulfate) based on receving pediatric exclusivity. Exclusivity for the drug in the US is now scheduled to expire on May 17, 2012.

Catalent Pharma Solutions, a provider of development, technology, and manufacturing services, entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a recombinant human interferon beta compound being developed for the treatment of multiple sclerosis. Catalent will produce NU100 at its facility in Brussels, Belgium, where the product will be formulated, filled, and packaged in a prefilled syringe. Nuron Biotech plans to begin Phase III clinical trials of NU100 in 2011.

EMD Millipore, the life science division of Merck KGaA of Germany, formed an agreement with Novo Nordisk to transfer the distribution of recombinant human insulin for cell-culture media to Novo Nordisk. Starting on May 1, 2011, recombinant human insulin products for cell-culture media applications, branded by EMD Millipore as Incelligent SG and Incelligent AF, will be supplied directly from the manufacturer, Novo Nordisk.

Endo Pharmaceuticals formed an oncology drug-development pact with Orion, a pharmaceutical and diagnostic company. The collaboration enables the companies to develop eight "discovery phase" candidates by combining an equal number of programs. In addition, under the agreement both companies can exclusively license the others' development-ready programs at predetermined stages and share all development costs.

Genzyme will allow sanofi aventis to conduct due diligence in consideration of sanofi aventis' bid to acquire Genzyme. A company statement said that discussions between the companies are ongoing, but that Genzyme can provide “no assurance” that the discussions will result in any particular transaction.

GlaxoSmithKline and Actelion discontinued the clinical development of the Phase III investigational dual orexin receptor antagonist, almorexant. The decision follows a review of data from additional clinical studies, which were conducted to further establish the clinical profile of almorexant, including the tolerability profile, according to a company press release.

H3 Biomedicine, a new biopharmaceutical company focused on personalized medicine, launched research and development operations. Pharmaceutical company Eisai has pledged up to $200 million in research funding to H3 Biomedicine, as well as additional clinical-development support. See a related blog post on PharmTech Talk.

Johnson & Johnson and the biopharmaceutical company Crucell received approval of J&J’s proposed acquisition of Crucell from the European Commission. A company statement detailed the remaining timetable of the offer process, which includes a Feb. 8, 2011, offer extraordinary general meeting, and a Feb. 16 acceptance closing time.

Pfizer completed its tender offer for all outstanding shares of common stock of King Pharmaceuticals at a purchase price of $14.25 per share. The shares validly tendered and not validly withdrawn represent approximately 92.5% of the outstanding shares of King common stock. Pfizer intends to complete the acquisition of King through a short-form merger  on or about February 28, 2011, and King will become a wholly owned subsidiary of Pfizer.

Pfizer will close its research and development (R&D) facility in Sandwich, UK, the company said in its fourth-quarter report. The Sandwich facility conducts research in the therapeutic areas of allergy and respiratory disease. Additional changes to Pfizer’s R&D operations include shifting selected resources from its Groton, Connecticut, plant to Cambridge, Massachusetts, and outsourcing certain functions. Pfizer plans to enhance its presence in Cambridge, UK, and in the US in Cambridge, New York, San Francisco and La Jolla, California.

Seven major research-based medical centers in New York City, including Rockefeller University, NYU Langone Medical Center, Memorial Sloan-Kettering Cancer Center, The Mount Sinai Medical Center, Columbia University Medical Center, Albert Einstein College of Medicine of Yeshiva University, and Weill Cornell Medical College, have joined Pfizer’s Centers for Therapeutic Innovation, a network of partnerships that aims to speed the translation of biomedical research into medicines. The first Center was established in November of last year at the University of California, San Francisco.

sanofi aventis and its US consumer healthcare division, Chattem, received FDA approval for the over-the-counter use in adults and children two years of age and older of the Allegra (fexofenadine HCl) family of allergy medication products. The drug will be available without a prescription in March 2011.

Tibotec Pharmaceuticals, part of Johnson & Johson, granted licenses to generic-drug manufacturers, including Hetero Drugs, Matrix Laboratories (a Mylan company), and Aspen Pharmacare, to manufacture, market, and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1-infected adults. Under the agreement, the generic-drug manufacturers will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product.

The recall of Triad brand alcohol prep pads due to possible contamination prompted pharmaceutical manufacturers to issue statements about their products packaged with the affected pads. Pfizer and Progenics Pharmaceuticals advised customers not to use the Triad pads packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) subcutaneous injection in the US. Merck issued a similar warning about the recalled pads to customers who use Pegintron (peginterferon alfa-2b) single dose RediPen and Pegintron vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and Intron A (interferon alfa-2b) Multidose RediPen and Intron A solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad Group recall.

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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

People Notes

Contract manufacturing organization AMRI appointed Takeshi Yura assistant director of medicinal chemistry. Yura will report to Managing Director Raymond Yeung at the company's drug-discovery services operations in Singapore.

E. Morrey Atkinson joined Cook Pharmica as vice-president of research and development and chief scientific officer. He was previously head of biotechnology manufacturing sciences and technology at Eli Lilly.

Delenex Therapeutics, a biotechnology company, appointed Eric de La Fortelle as its CEO and Jakob Schlapbach as its CFO.

Susan Schniepp, vice-president of quality at OSO BioPharmaceuticals Manufacturing has been elected to the board of directors at the Parenteral Drug Association. Schniepp also is a member of Pharmaceutical Technology’s editorial advisory board.

Pfizer appointed Yvonne Greenstreet senior vice-president and head of medicines development for its specialty-care business unit. Greenstreet succeeds Michael Berelowitz, who is retiring. Greenstreet will report directly to Geno Germano, president and general manager of Pfizer’s specialty-care business unit.

Global specialty biopharmaceutical company Shire appointed Emmanuel Chantelot, former executive director of European Biopharmaceutical Enterprises, as director of European government relations and public policy.

Regulatory Roundup

FDA will hold its fourth orphan-drug designation workshop for academics, biotechnology companies, and those unfamiliar with the orhan-drug designation process Feb. 28–Mar. 1, 2011, in Claremont, California, in collaboration with Keck Graduate Institute, according to an agency announcement. The workshop will focus on the process used by FDA to grant orphan-drug designation to drug products intended to treat rare diseases. Three similar workshops were held in 2010.

PharmTech, the magazine
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Are you spending more or less on pharmaceutical equipment? Are you seeking greater innovation in pharmaceutical machinery? Pharmaceutical Technology is interested in your input on the trends affecting the level of spending and innovation in equipment and machinery for pharmaceutical manufacturing. If you are involved with (operate, process products through, supervise, suggest, purchase, or review expenditures for) pharmaceutical machinery and equipment within your company, we invite you to take a few minutes to participate in our annual survey. Results are kept completely confidential, and participants will be eligible to win of three $100 gift certificates. Results will be published in the March 2011 issue of the magazine.
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Coming Soon: Next month’s ingredients column examines the global supply chain for active pharmaceutical ingredients in the March issue of Pharmaceutical Technology.

Contract Manufacturers Gear up for Informex 2011
By Patricia Van Arnum
As the industry prepares for Informex, the trade show of custom and batch manufacturers in Charlotte, North Carolina, a roundup of key recent developments.Click Here to Read More
 

 
 
 
 
 
 

PharmTech Poll

Outsourcing Levels
How would you describe the level of outsourcing for active pharmaceutical ingredients or pharmaceutical chemical development services?

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